Clinical Trial ID: NCT03498716
A Phase III, Multicenter, Randomized, Open-Label Study Comparing ATEZOLIZUMAB (Anti-PD-L1 Antibody) in Combination with Adjuvant ANTHRACYCLINE/TAXANE-Based Chemotherapy Versus Chemotherapy Alone in Patients with Operable Triple-Negative Breast Cancer
This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)
The primary objective of Study BIG 16-05/AFT-27/WO39391 is to evaluate the efficacy of adjuvant treatment with atezolizumab T-AC/EC compared with T-AC/EC alone in patients with newly diagnosed TNBC as measured by iDFS.
Experimental: Atezolizumab + Chemotherapy
Participants will receive atezolizumab (in combination with chemotherapy as described below) every 2 weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose. Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Active Comparator: Chemotherapy
Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF). Paclitaxel will be administered by IV, 80 mg/m every week for 12 weeks.
Baptist MD Anderson Cancer Center
- Non-metastatic operable Stage II-III breast cancer
- Histologically documented TNBC (Triple Negative Breast Cancer)
- Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen
- Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
- No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization.
- Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides.
- Prior history of invasive breast cancer
- For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy.
- Previous therapy with anthracyclines or taxanes for any malignancy
- Cardiopulmonary dysfunction
- Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Urinary outflow obstruction
- Active tuberculosis
- Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment or within 5 months following the last dose of Atezolizumab (for patients randomized to Atezolizumab)
- Prior allogeneic stem cell or solid organ transplant
- Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study
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